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Step plan, side effects & Pharmacovigilance

There is an ongoing benefit-risk evaluation is necessary. There is an ongoing benefit-risk evaluation is necessary. As soon as side effects, interactions need to be aware they are published. As soon as side effects, interactions need to be aware they are published. The task of pharmacovigilance is thus a risk minimization. The task of pharmacovigilance is a risk minimization Thus.

Pharmacovigilance is particularly necessary when the preparations, the clinical stage in their few participants, no average patients and smoking, age, pregnancy had. Pharmacovigilance is Necessary Particularly when the preparations, the clinical stage in their few participants, no average patients and smoking, age, pregnancy had.

Side effects Side effects

Side effects are defined in the AMG can occur under normal use and can Harmful unintended response = Adverse drug effects Side effects are defined in the AMG Can Occur under normal use and can Harmful unintended response = Adverse Drug Reactioncause (ADRs) / adverse drug reaction (ADR). cause (ADRs) / adverse drug reaction (ADR). As serious side effects are known, especially if As serious side effects are known, especially when

A phased approach is generally an administrative regulation on the collection, monitoring, and evaluation of drug risks, by all authorities and departments that deal with drug risks. A phased approach is gene rally to administrative regulation on the collection, monitoring, and evaluation of drug risks, by all Authorities and departments that deal with drug risks.

Security Level 1: Security level 1:Effective immediately at Verdcht to a new side effect, can new clinical BfArM. Effective immediately at Verdcht to a new side effect, can new clinical BfArM. Studies or information required by the manufacturer. Studies or information required by the manufacturer.

Security Level 2: Security level 2:If there is reasonable suspicion of unacceptable risks may BfArM bans, recalls and arrange deposits. If there is reasonable suspicion of unacceptable risks may BfArM bans, recalls and arrange deposits.